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Procedure
Laser Ablation for Prostate Cancer (TPF-LITT Trial)
N/A
Recruiting
Led By Fernando J Bianco, MD
Research Sponsored by Urological Research Network, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI
Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
TPF-LITT Trial Summary
This trial assesses the safety & tolerance of a new prostate cancer treatment that's done in the office setting under local anesthesia to preserve organ function & reduce surg. risk.
Who is the study for?
Men aged 50-80 with low to intermediate risk prostate cancer, who can consent and follow the study plan. They should have a prostate size of 18-100 cc by ultrasound or MRI, PSA <20 ng/ml, no urinary retention, creatinine levels <2 ng/dl with GFR >45. Excluded are those with neurogenic bladder issues, poor sexual function scores (SHIM score <14), surgery risks like infection or coagulopathy, high post-void residual urine volume (>250 mL), prior prostate cancer treatments or major neurological conditions.Check my eligibility
What is being tested?
The trial tests TRANBERG® TPF-LITT for treating prostate tumors in an office setting under local anesthesia. It aims to preserve organ function while targeting tumor ablation using fusion imaging guidance. The study will evaluate safety and tolerance of this minimally invasive procedure and its effects on urinary and sexual functions as well as MRI changes in the treated area over time.See study design
What are the potential side effects?
Potential side effects may include discomfort from the laser therapy itself, possible impacts on urinary function leading to incontinence issues, changes in sexual function including erectile dysfunction or altered ejaculation following treatment.
TPF-LITT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate size is between 18 and 100 cc according to an MRI.
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My prostate cancer is at an intermediate risk level and occupies less than a third of my prostate.
Select...
I do not have problems emptying my bladder completely.
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My prostate size is between 18 and 100 cc as measured by ultrasound.
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My kidney function is normal, with creatinine levels below 2 ng/dl and GFR above 45.
TPF-LITT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.
Secondary outcome measures
Average Ablated area volume (in cc) measured by MRI 1-month following the procedure
Average Ablated area volume (in cc) measured by MRI 1-year following the procedure
Average Ablated area volume (in cc) measured by MRI 3-month following the procedure
+7 moreTPF-LITT Trial Design
1Treatment groups
Experimental Treatment
Group I: TPF-LITT ARMExperimental Treatment1 Intervention
partial gland ablation of the prostate using laser device and imaging fusion
Find a Location
Who is running the clinical trial?
Urological Research Network, LLCLead Sponsor
4 Previous Clinical Trials
10,170 Total Patients Enrolled
Fernando J Bianco, MDPrincipal InvestigatorUrological Research Network
1 Previous Clinical Trials
150 Total Patients Enrolled
Isabel H Lopez, BS., MBAStudy DirectorUrological Research Network
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study procedures and attend all visits.I do not have major neurological conditions like Alzheimer's or Parkinson's.I cannot have local anesthesia due to health reasons.I cannot have TPFLA surgery due to a health condition like an infection or heart risk.My prostate size is between 18 and 100 cc according to an MRI.I have had bladder or urethra issues in the last 5 years.My prostate cancer is at an intermediate risk level and occupies less than a third of my prostate.I have acute prostatitis.I have had radiation therapy or major surgery in my pelvic area.You have a current urinary tract infection confirmed by a urine test.You have had a specific type of MRI for your prostate that shows certain scores.You have been diagnosed with a neurogenic bladder through specific tests.You have a sexual health score lower than 14.Your IPSS score is higher than 23.If you have more than 250 mL of urine left in your bladder after going to the bathroom, or if the amount left is more than half of what you just peed.I have visible blood in my urine without any known cause.I have bladder stones.I do not have problems emptying my bladder completely.My prostate size is between 18 and 100 cc as measured by ultrasound.Your PSA blood test results are less than 20 ng/ml.I have had treatments like radiation or cryoablation for prostate cancer.I have been using a catheter or performing self-catheterization in the last 30 days.My kidney function is normal, with creatinine levels below 2 ng/dl and GFR above 45.I had surgery for colorectal cancer involving the removal of part of my rectum.I have a bleeding or blood clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: TPF-LITT ARM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor accept individuals over the age of 55?
"This clinical trial is open to individuals aged 50-80. Those younger than 18 or older than 65 may still find a suitable study, as there are 90 trials for minors and 1459 studies available to those over the age of 65."
Answered by AI
Are there still vacancies available in this experiment for participants?
"Affirmative. According to clinicaltrials.gov, the research is currently recruiting patients after its initial posting on March 16th 2022 and last update January 24th 2023. The trial seeks out twenty participants from a single medical centre."
Answered by AI
Who can take advantage of this research opportunity?
"This clinical study is seeking 20 individuals aged 50-80 with prostate cancer. Patients must meet various criteria, including the ability to sign informed consent documents and complete follow up visits; an absence of urinary retention; a serum creatinine level below 2 ng/dL and a GFR above 45; PSA levels under 20 ng/ml; Multiparametric MRI scores 3-5 for piRADS evaluation of their prostate volume between 18-100 cc in size, indicating intermediate risk prostate cancer with less than 1/3 glandular tissue present."
Answered by AI
How many participants are currently engaging in this research project?
"Affirmative. Clinicaltrials.gov corroborates that the research project, which was initially put forward on March 16th 2022, is proactively recruiting participants. So far it has sought 20 individuals at one trial site."
Answered by AI
Who else is applying?
What site did they apply to?
Urology Specialist Group
What portion of applicants met pre-screening criteria?
Met criteria
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